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Korea License Holder (KLH)
BCG holds and manages your Korean approval. Enter Korea without a local entity and choose or change distributors freely.
When it fits
Avoid tying the approval to a distributor
Change distributors or work with several
When is this service useful?
To sell a medical device in Korea, a company holding a Korean importer licence must obtain the product notification, certification or approval. BCG holds importer licences for medical devices and IVDs and can act as the Korean licence holder for overseas manufacturers. Because the approval is not tied to a distributor, changing distribution does not require a new approval.
What BCG takes on
Korean approval holder
BCG obtains the product authorization in its name and manages the holder's obligations.
Distributor independence
The approval is not tied to a distributor, so you can choose or change partners and keep it.
Post-approval obligations
Changes, renewals, quality management and safety reporting after approval are managed together.
Prepare for your review
- Product description and intended use
- Overseas approval status
- Planned distribution and sales
- Manufacturer quality and test evidence
How We Work
Confirm the entry model
Review the product, distribution plan and the roles of the manufacturer, BCG and distributors.
Agree roles by contract
Set approval holding, document supply, change notification and cost scope.
Obtain the approval
BCG files the product authorization and any KGMP response in its name.
Hold and maintain
Manage maintenance, changes, renewals and distributor coordination.
Separate distribution from the approval
The approval stays with BCG, so a distributor change needs no new approval and the manufacturer negotiates distribution independently.
The specific scope and deliverables are agreed after product and evidence review.
Frequently Asked Questions
What should we prepare for an initial discussion?
Product information, intended use, manufacturing details, approvals and available testing evidence.
When can timing be estimated?
After likely classification and material evidence gaps have been reviewed.
MFDS medical-device regulations · MFDS medical-device approval process · Content baseline · Check current requirements for the specific product
CONSULTATION
Start a consultationClarify the Korean regulatory pathway for your product.
Attach what you have and we will reply by email after reviewing it. You do not need a complete set of documents.